MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUGE; WIRE, GUIDE, CATHETER

Model Number	2747
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in the bifurcation of the diagonal branch and left anterior descending (lad) artery.Two 182cm luge guidewires was used to cross the lesion with one for diagonal branch and one for lad.Intervention was completed.The first wire was pulled out, but while the physician pulled the second wire there was a detached tip left in lad.It was uncertain which wire the tip detached from.The procedure was completed by successfully snaring the tip and with a use of a different device.There were no patient complications reported.
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in the bifurcation of the diagonal branch and left anterior descending (lad) artery.Two 182cm luge guidewires was used to cross the lesion with one for diagonal branch and one for lad.Intervention was completed.The first wire was pulled out, but while the physician pulled the second wire there was a detached tip left in lad.It was uncertain which wire the tip detached from.The procedure was completed by successfully snaring the tip and with a use of a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The device has its distal section kinked.Additionally, the device was broken 179.2 cm from proximal to broken section, total length should be 182 cm.The other part of the device was not returned.The outer dimensions of the middle and proximal sections of the device were within specifications.

• Brand Name: LUGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8394625
• Report Number: 2134265-2019-02092
• Device Sequence Number: 2926623
• Product Code: DQX
• UDI-Device Identifier: 08714729252320
• UDI-Public: 08714729252320
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/20/2020
• Device Model Number: 2747
• Device Catalogue Number: 2747
• Device Lot Number: 22975204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2019
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR